Funding a SHAP clinical evaluation kit for an e-NABLE clinical study in South Florida (Nicklaus Children's Hospital, Miami, FL)

Research Funding Proposal: Scan2Make, The Bionic Glove Project et al.

-Proposal Background

The Bionic Glove Project, a registered 501 c3, has worked over the last 9 months to develop a novel five (5) year pilot study evaluating the efficacy of 3-D scanning for custom fitting of eNABLE devices and designing novel devices to increase access to 3-D printed orthotic and prosthetic devices to upper limb amputees. BGP is sponsoring the clinical trial and has assumed all costs for preparation. This research utilizes a multidisciplinary team in conjunction with pediatricians, orthopedists, orthotists/prosthetists, physical therapists, case workers,other e-NABLE chapters such as Handling the Future, 501 c3 (Tampa Bay area), and other clinical partners.

The clinical trial, entitled Scan2make has recently been given a greenlight for IRB approval (submitted independently by Nicklaus Children's Hospital) pending finalization of research agreements; however, in anticipation of the study, we are moving forward with our research funding request with the idea that the trial shall begin in December 2018 or January 2019. This will also allow us to finalize enrollment the clinical study on the FDA’s clinicaltrials.gov.

A critical part of this study will use a well-documented, standard clinical evaluation tool called the Southampton Hand Assessment Procedure (SHAP) (http://www.shap.ecs.soton.ac.uk/ ). Previously, our research collaborator has used this kit for evaluations of users with neurotrauma, and is an ideal clinical evaluator with 23 different options to test dexterity, grip, control, etc. for device testing in this study as well. We are seeking assistance to funding of £ 2050 ($2665) to purchase a kit, which will be provided to Nicklaus Children’s Hospital to evaluate e-NABLE devices and customized solutions for upper limb amputees in a clinical settings. The biggest aims are to evaluate the many different designs and fitting practices for a wide range of varying upper limb amputees, and understand where there may be an ideal device or practice for specific clinical case types. The e-NABLE community will also gain access to the protocols and will be informed regularly on updates. Many of the SHAP objects can be replicated, and another aim of this will be to identify the applicable SHAP tests that e-NABLE makers can perform for gaining feedback on previous and custom-made devices. A quality of life survey, PedsQL, will be administered to ascertain psychosocial feedback as well from the user.

-Motivation

The South Florida area has a population of over 6.6 million people (1), and The Bionic Glove Project has been approached with over 10 potential cases in the last year ranging from the the West and East coast of South Florida, 7 were deemed eligible for devices, of which 4 were e-NABLE devices including the Team UnLimited Arm, Raptor Reloaded 2 hand, and Phoenix V2 hand. One in five thousand children are born with a genetic birth defect which affects the growth of their hand(s), one in twenty thousand are born with hand defect caused by their arm, hand or fingers being occluded and constricted by the amniotic sac known as Amniotic Band Syndrome (2) Regarding congenital limb amputation, anomalies affecting only the hand plate accounted for 62% (296) of the malformations. Of these, radial polydactyly (15%) was the most common specific anomaly, followed by symbrachydactyly (13%) and cleft hand (11%) (2,3). Additionally, other cases which have presented include central deficiency which there have been 0.52/10,000 cases of this nature are reported annually. (3,4) It is then estimated that there are over two million amputees in the US ten million people worldwide (5,6) are in need some form of hand supplementation using a Personal Assistive Device , be it an e-NABLE or custom made design. This is apparent as healthcare costs for amputees are on the order of over 35% greater than able-bodied persons over their lifetime (5,6,7). This motivates a solution for adaptive devices that are low-cost and custom to the user. Furthermore, additional limitations are increased with physiological variation within the multiple degrees of congenital and acquired amputations, and further complicates the ability to streamline an active process for rapid prototyping and directly 3-D printing prosthetics with good manufacturing practice for upper limb amputees. This highlights the need to develop a strategy that can overcome this major barrier to provide custom-fit prosthetic solutions. To address this need, 3D scanning has been used in a clinical setting for both orthotics (8) and for prosthetic devices (9) to develop custom sockets and attachments for upper limb amputees (10).

The Bionic Glove project is committed to finding the best custom-fit orthotic and prosthetic devices for patients, while holding their safety and quality of care to the highest regard. They team with local medical, pediatric, orthopedic, and orthotist and prosthetist specialists to develop tools to address challenges for providing custom fit prosthetics for patients in the South Florida community. Previously, using 3-D scanning, the BGP has made customized flexible sockets for myoelectric integration (http://bit.ly/2Obc0AK), customized orthotic devices for e-NABLE cases without a custom or premade solution such as for cases with central deficiency (case 507) (http://bit.ly/2PmZgU5) or complex amniotic band syndrome (http://bit.ly/2IKT5a6). Therein, a standardized process can be developed using low-cost 3-D scanning and CAD to deliver a customized 3-D printed device for typical and unique upper limb amputee cases. To evaluate the efficacy of functional prosthetics, standardized clinical tests, like SHAP, test can be applied to measure the the degrees of freedom, functionality and quality of life for each case. Thus a full clinical trial is warranted to understand the benefits of integrating 3-D scanning and printing technologies for increasing access to customized prosthetic technology to upper limb amputees

-Budget Request
Southampton Hand Assessment Procedure kit to provide to Nicklaus Children's Hospital (Miami, FL) Cost: £2050.00 ($2665.00).

-Proposal

Research Plan:

Phase Timeline of Design Study by Year
Timeline figure: http://bit.ly/2ype3X9

A pilot study will attempt to recruit 50 participants from South Florida, which will take place over a five (5) year pilot period to allow for time for recruitment, due to the relatively low incidence of congenital hand deformities. The scanning technology used is widely commercially available, low cost and optimal for versatile point-of-care application. Initially this technology will be adopted into a design process, incorporating other CAD tools to enable a powerful and standard method of rendering custom fit prosthetics. Participant recruitment will begin following a formulized standard scanning and design strategy. Next, a toolset of parts that can be adapted to the 3-D scan will then be created. Once enrollment begins, participants will be asked to be evaluated for a prosthetic and 3-D scanned, then fitted. Non-adult participants (ages 2-17) will be asked to perform the PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) two weeks after fitting, and participants thirteen (13) and older will be asked to perform a SHAP test to evaluate the ability of the custom fit prosthetic.

Research Methods:

Research Study Participant Involvement Timeline by Month
Timeline figure: http://bit.ly/2E9XhBm

First, after the potential participant has contacted the P.I. and expressed interest in the study, the participant or parent/guardian will be given an initial questionnaire via mail in a pre-stamped, self-addressed envelope, upon receiving interest in recruitment.

Within two (2) weeks, the Bionic Glove Project (BGP) will arrange for a clinical visit to ensure the participant meets all criteria to enter the study. This will involve likely a one (1) hour visit to the clinician office or at FAU. The participant will be asked to travel to the chosen clinic closest to the participant’s location.

If the participant meets all appropriate criteria, they will then be 3-D scanned. The scanning can take up to twenty (20) minutes and can be done at the clinic after evaluation. Alternatively, if the participant would like to request another appointment for 3-D scanning at Dr. Erik Engeberg’s BioRobotics Lab or another partner clinic they can do so. The prosthetic will be created from the participant’s 3-D scan using computer design software and will be printed out and assembled.

Once ready six (6) weeks from the participant’s initial scan, the participant will be asked to meet at a chosen clinic or at the BGP for a fitting. This can take up to one (1) hour, and consists of ensuring the prosthetic fits, using patient-feedback to enhance padding for their desired custom fit. The participant will also be instructed to use and care for their prosthetic.

Additionally, Teen and Adult participants, aged thirteen (13) or older, will be asked to perform a physical evaluation using the Southampton Hand Assessment Procedure (SHAP). This procedure will be conducted in five (5) minute intervals with ten (10) minutes of rest in between each trial attempt. The participant will be asked to perform a total number of four (4) trials for a total of one (1) hour.

The participant will be followed up two (2) weeks after the fitting to follow-up on the prosthetic and will be requested to complete a twenty (20) minute mail-in survey (PedsQL) depending on age of the participant, sent to the participant or participant’s parents/guardians for evaluation of the prosthetic, via mail in a pre-stamped, self-addressed envelope.

The participant will receive no financial compensation but will be able to keep the custom fit prosthetic for free, and have access to free future custom fit prosthetics, if desired, even if participation is ended prior to study completion.

Analysis Plan:

Analysis shall be three-fold. The first will be a quantitative measure of the ability to make the prosthetics with be measure in terms of time from scan to fitting the patient, materials and extra support hardware (e.g. machine screws, straps, 7x7 leader wire, wire crimps, and 3/8-inch rubber bands), and the burden of labor documented for each step in the design process.

Secondly, If the participant is age 2-18, parents the will be asked to fill out PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) Parent Report for either Toddlers (ages 2-4), Young Children (ages 5-7), Children ages (8-12), or Teen (ages 13-18). Child (ages 8-12) and Teen participants (ages 13-18), will be asked to either take the PedsQL Child Report (ages 8-12) or Teen Report (ages 13-18), respectively. These are standardized, verified quality of life surveys. Parents/guardians of participants will be asked to complete surveys after informed consent is obtained. Surveys will be sent out and collected via mail in a pre-stamped, self-addressed envelope. Survey data will be stored in a locked drawer located in the BGP’s office.

Assessments Utilized by age:
2-4
PedsQL Parent Report
5-7
PedsQL Parent Report
8-12
PedsQL Parent and Child Report
13-17
PedsQL Parent and Teen Report, SHAP Test
18<
SHAP Test

Finally, Teen and Adult participants, ages thirteen (13) and older will be asked to conduct a Southampton Hand Assessment Procedure (SHAP) test, where they will be asked to perform various tasks including: grasping various objects on a flat surface and picking them up and place them into a target space or conveying a specific function such as rotating a screw or squeezing an irregular object.

-Resources

The BGP has all of the equipment necessary for this research, including 3-D printers, hardware, access to computers for CAD rendering and scanning infrastructure. Including P.I., Dr. Erik Engeberg of the FAU BioRobotics Lab, Dr. Patricia Anastasio M.D. of Pediatric Associates of Boca, Richard Brown, DO, of Handling the Future, Inc., Dr. Aaron Berger, MD. Ph.D., of Nicklaus Children’s Hospital, and David Falk, LPO CPO of Falk Prosthetics & Orthotics, John Calloway of Halo Technologies, LLC. and Christopher Scull or Delta Design, LLC. will be staff on this study. Clinical services such as physicals and fittings may be rendered at these locations. Any kind of social or medical services are extremely unlikely to be needed, but are within short distance of the Boca Raton FAU campus and any of the off-site locations.

Pediatric Associates of Boca, Nicklaus Children’s Hospital, and Falk Prosthetics & Orthotics; At these clinics sites, clinicians may use X-rays to help evaluate if the participant meets the study criteria.

Halo Technologies, LLC., Delta Design, LLC., are engineering manufacturers that will offer knowledge and expertise in CAD and 3-D Scanning and printing of rendered custom fit prosthetics.
Handling the Future, Inc. consists of a group of senior e-NABLE volunteers that fabricate and deliver 3-D printed prosthetics to amputees. They will contribute their subject-matter expertise, assist in scanning and socket fabrication and delivery.

-Outcomes

Innovation and Technology Development:

The study will lead to a standardized 3-D scanning technique for developing custom-fit 3-D printed orthotics and prosthetics and evaluated in clinical settings

Indirectly, case-specific prosthetics that are not currently being met with e-NABLE device designs will be made and delivered open-source.

Current e-NABLE devices will also have the opportunity to be evaluated in the clinical setting, dependent on case presentation, and tested through use of the SHAP .

SHAP tests that can be implemented on e-NABLE devices for clinical testing will be identified, and made available to the community.

-Community Engagement and Pedagogical Development

Promote local university and high school student volunteers enabling access to those with limb difference in the South Florida and contribute to global e-NABLE Community.

Allow student access to new and beneficial technology, and teaching them the importance of integrating such useful technologies in the most helpful of ways.

Creation of a platform for inquiry-based learning which incorporates the most effective and creative teaching practices to drive an environment capable of fostering passion and developing innovation.

-Citations

US Census, 2016 visited 9/26, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=PEP_2016_PEPANNRES&amp;prodType=table

Charles A. Goldfarb, Lindley B. Wall, Deborah C. Bohn, Patrick Moen, Ann E. Van Heest, Epidemiology of Congenital Upper Limb Anomalies in a Midwest United States Population: An Assessment Using the Oberg, Manske, and Tonkin Classification, The Journal of Hand Surgery, Volume 40, Issue 1, 2015, Pages 127-132.e2, ISSN 0363-5023, https://doi.org/10.1016/j.jhsa.2014.10.038.

Koskimies E, Lindfors N, Gissler M, Peltonen J, Nietosvaara Y. Congenital upper limb deficiencies and associated malformations in Finland: a population-based study. J Hand Surg [Am] 2011;36:1058–1065.; Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4094123/

Dy, Christopher J., Ishaan Swarup, and Aaron Daluiski. "Embryology, diagnosis, and evaluation of congenital hand anomalies."Current reviews in musculoskeletal medicine 7.1 (2014): 60-67.) Link: https://www.ncbi.nlm.nih.gov/pubmed/24515896

Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation2008;89(3):422‐9.

Center for Health S. Ambulatory and Inpatient Procedures in the United States, 1996. Hyattsville, Md.: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 1998.

HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). Rockville, MD: Agency for Healthcare Research and Quality; 2009.

Volonghi, Paola, Gabriele Baronio, and Alberto Signoroni. "3D scanning and geometry processing techniques for customised hand orthotics: an experimental assessment." Virtual and Physical Prototyping 13.2 (2018): 105-116.

Liacouras, Peter C., et al. "Using computed tomography and 3D printing to construct custom prosthetics attachments and devices." 3D printing in medicine 3.1 (2017): 8.

Tian, Li, et al. "A Methodology to Model and Simulate Customized Realistic Anthropomorphic Robotic Hands." Proceedings of Computer Graphics International 2018. ACM, 2018.